*ONIVYDE® for 2L SCLC Phase III trial Did Not Meet Primary Endpoint

*ONIVYDE® Showed a Favorable Safety and Tolerability Profile among Study Participants that was Consistent with Prior Clinical Trial Results

*The clinical study results will be communicated with the regulatory agency by IPSEN

 

PharmaEngine's corporate partner, IPSEN. (Euronext: IPN; ADR: IPSEY) has announced results from the RESILIENT Phase 3 multicenter, randomized, controlled study evaluating ONIVYDE® as a single agent for the treatment of small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen.

 

RESILIENT is a phase 3, open-label study with a planned sample size of 450. Patients are randomly allocated 1:1 to intravenous ONIVYDE® or intravenous topotecan. ONIVYDE® is administered every 2 weeks at 70 mg/m2 (free-base equivalent) and topotecan is administered for 5 consecutive days every 3 weeks at 1.5 mg/m2. Tumor assessments are performed using the Response Evaluation Criteria in Solid Tumors version 1.1 and the Response Assessment in Neuro-oncology criteria for CNS lesions; symptom improvement is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Safety assessments include monitoring for adverse events.

 

The study did not meet the the primary endpoint of overall survival (OS) in patients with SCLC comparing ONIVYDE® to the control arm, though there was no adverse effect on OS with the experimental arm. Based on the study design, analyses of the secondary endpoint of objective response rate (ORR) favored the ONIVYDE® arm. The safety data in this study was consistent with the Part I of RESILIENT trial with no new safety signals observed. The experimental arm showed favorable safety and tolerability regarding Grade-3 or greater drug related adverse events (AEs), deaths due to AEs, hematologic toxicity, dose reductions and treatment discontinuations due to AEs, compared to the control arm. Results will be discussed with the appropriate regulatory authorities and will be presented at a future medical meeting. For further information regarding IPSEN's press release, please refer to the following linkhttps://www.ipsen.com/press-release/.